Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (O
Summary
The FDA issued a Class II for Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID- by CUE HEALTH INC. Reason: Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization..
Details
Source
Device Recall
External ID
Z-0091-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Lot/Code Info: Product code: 2900005 UDI code: N/A Lot Numbers: 30757C 30761G 30760C 30884G 30885G 30762G 30886G 30879C 30882C 30918C 30889G 30926G 30923C 31032G 30924C 31040C 31041C 31033G 31042C 31043C 31044C 31036G 31045C 31046C 31037G 31158C 31162C 31161C 31165B 31163E 31166B 31038B 31374B 31373E 31400B 31465E 31464B 31403B 31408E 31404B 31476B 31410E 31477B 31478B 31540B 31541B 31542B 31543B 31544B 31545B 31546B 31479B 31480B 31537L 31739L
Quantity Affected: 56 Lots (248,109 total kits)
Reason for Recall
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Distribution
U.S. Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-24
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CUE HEALTH INC has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CUE HEALTH INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CUE HEALTH INC have FDA actions?
CUE HEALTH INC has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0091-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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